NovaTears® Eye Drops Observational Study

Dry Eye Disease Clinical Trial

Official title:

NovaTears® Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111928
• Other study ID #: NT-001
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: October 5, 2015
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• According to NovaTears® instruction for use

• = 18 years

• Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days

• Ability and willingness to provide written Informed Consent

• Ability and willingness to participate in all examinations

• Willingness and ability to return for follow up visit

Exclusion Criteria:

• Patients with hypersensitivity to any of the components of NovaTears®

• Patients with contact lenses, pregnancies, or who are breast feeding

• Patients with non evaporate dry eye disease

• Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

Intervention

Device:
• NovaTears® Eye Drops
Topical eye drops for lubrication of the ocular surface

Locations

Country	Name	City	State
Germany	Praxis Dr. Kaercher	Heidelberg
Germany	Zentrum fuer Augenheilkunde Uniklinik Koeln	Koeln

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy measured by routine ophthalmological assessment	Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia.	5 to 7 weeks	No
Secondary	Local Tolerability measured by ophthalmological assessment		5 to 7 weeks	No